The present invention relates to medical devices used in combination with guide members. More specifically, the present invention relates to intravascular balloon dilatation catheters for use in combination with guide wires, and in particular, to those intravascular balloon dilatation catheters referred to as single-operator-exchange, rapid exchange or xe2x80x9cmonorailxe2x80x9d catheters used in combination with guide wires. The inner surface of the catheter shaft which receives the guide member is filled with a lubricious material to eliminate the need for flushing the catheter device before surgical procedures. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein.
Intravascular diseases are commonly treated by relatively non-invasive techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). These therapeutic techniques are well-known in the art and typically involve the use of a balloon catheter with a guide wire, possibly in combination with other intravascular devices such as a stent. A catheter may also be used with a self-expanding stent alone. A typical catheter system has an elongate shaft with a device such as a balloon and/or stent attached to the distal end and a manifold attached to the proximal end. In use, the catheter is advanced over the guide wire such that the device positioned adjacent a restriction in a diseased vessel. The balloon is then inflated or the stent released and the restriction in the vessel is opened.
In particular, a typical angioplasty procedure requires inserting at least a guide catheter and a dilatation catheter into the vascular system of a patient to open a stenosis within that vascular system. There are two basic types of catheters used in combination with a guide wire. One type is an over-the-wire catheter. The second type is a modification of the basic over-the-wire catheter and is referred to as a single-operator-exchange (SOE) catheter or rapid exchange catheter. The construction and use of both OTW catheters and SOE catheters are well-known in the art.
The standard over-the-wire catheter has an inner or guide wire lumen that extends from the distal end of the catheter to the proximal end of the catheter. A manifold is attached at the proximal end of the catheter to provide an attachment for fluid communication with the guide wire lumen.
A single operator exchange catheter (SOE catheter), is a variation of the over-the-wire catheter. SOE catheters are commonly referred to in the art as rapid exchange catheters or xe2x80x9cmonorailxe2x80x9d catheters. SOE catheters have a guide wire lumen that only extends through a portion of the catheter. The guide wire lumen extends from the distal end of the catheter to a distal porthole on the catheter tube.
An example of an OTW catheter may be found in U.S. Pat. No. 5,047,045 assigned to SCIMED Life Systems, Inc. Examples of SOE balloon catheters are disclosed U.S. Pat. No. 5,156,594 and U.S. Pat. No. 5,549,552 both also assigned to SCIMED Life Systems, Inc.
The guide wire lumen is provided for standard over-the-wire catheters and for SOE catheters so that a guide wire can be used to establish a path through the vascular system to the stenosis of the patient. The use of the guide wire enables the catheter to be advanced through the blood vessel relatively quickly, thereby reducing the time required for the procedure.
A concern that arises during an angioplasty procedure occurs when the operator attempts to load the guide wire into the catheter while the guide wire is in the vascular system of the patient. Generally, the relative diameters of the guide wire and the guide wire lumen make it difficult for the operator to load the guide wire into the inner or guide wire lumen. Once again, this problem is magnified by the fact that the angioplasty procedure is generally performed in a darkened room.
Typically therefore, before placing the catheter over the guidewire, it is desirable to flush the guidewire lumen with a flushing solution, generally a saline solution, to eliminate contaminants and air in the guidewire receiving lumen, as well as to lubricate the inner surface so that the catheter can be slid over the guidewire more easily.
The flushing procedure for a standard over-the-wire catheter is relatively simple because a luer-fitting is attached to the manifold on the proximal end of the guide wire lumen. The operator can simply attach a standard syringe to the proximal end of the guide wire lumen and force flushing fluid through the lumen. The flushing procedure for an SOE catheter is more difficult to perform because there is no fitting on either end of the guide wire lumen to connect a syringe to the guide wire lumen.
The procedure used for flushing a xe2x80x9crapid exchangexe2x80x9d or xe2x80x9cmonorailxe2x80x9d catheter typically involves the use of a blunt needle connected to a syringe. An operator, such as a nurse, inserts the blunt needle into the distal opening of the guidewire receiving lumen and then forces flushing fluid from the syringe, through the needle, into the distal opening of the guidewire receiving lumen and then forces flushing fluid from the syringe, through the needle, and into and through the inner or guidewire receiving lumen of the catheter.
The guide wire lumen of an angioplasty catheter is generally very small in size. For example, an angioplasty dilatation catheter having a guide wire lumen with a diameter as small as 0.016 inches is common in the medical industry. Therefore, it is very difficult to insert a lumen flushing needle (which commonly has an outside diameter of 0.012 inches) within the guide wire lumen of such a catheter. This problem is magnified by the fact that an angioplasty procedure is generally performed in a darkened room, making it very difficult to see the guide wire lumen of the catheter and the needle.
This procedure also creates a situation that is inherently dangerous to the operator. It is extremely easy for the operator to accidently stick a finger while attempting to insert the needle into the lumen (xe2x80x9cneedle stickxe2x80x9d). Such an accident exposes the operator to a potential inadvertent transfer of dangerous or fatal diseases.
Using a needle and syringe can therefore be quite cumbersome, potentially dangerous and costly because the needle can puncture the balloon or the catheter, rendering the balloon catheter inoperable and increasing the risk to the patient.
Additionally, for some angioplasty procedures, more than one dilatating catheter having different balloon sizes or configurations may be used in a single procedure, or multiple stents may be inserted if the blockage is at a branch in a vessel, for instance. Therefore, it is common for the operator to remove a catheter from the vascular system and set that catheter aside to be reinserted at a later time in the procedure.
Another concern arises when the operator attempts to reinsert the catheter into the vascular system. This relates to the fact that the inner or guide wire lumen of the catheter has now been in fluid communication with the vascular system of the patient. Therefore, blood and other tissues from the patient may have collected within the guide wire lumen of the catheter. Such blood and tissue may coagulate and block the guide wire lumen of the catheter when the catheter is removed from the vascular system. The coagulated tissue then makes the catheter inoperable, since it prevents the operator from effectively guiding the catheter over the guide wire. Accordingly, the operator must flush the inner lumen of the catheter after removing it from the patient if the operator wants to reinsert the catheter later during the procedure.
There are numerous other medical procedures in addition to angioplasty that require an operator to use a lumen flushing technique similar to that described above. For example, some tissue collection procedures present the need for removing tissues from a collection chamber to perform further pathological studies on the tissue. There remains a need in the art for an efficient and effective means without exposing to the inherent dangers of the current needle-based method.
U.S. Pat. No. 5,598,844 describes a flushing device for use of xe2x80x9cmonorailxe2x80x9d or xe2x80x9crapid exhcangexe2x80x9d balloon catheters to solve the problems asociated with using a syringe and needle for flushing the guidewire receiving lumen of the catheter.
The present invention overcomes the aforementioned problems by filling the guide wire lumen with a lubricious material which eliminates the need for flushing prior to insertion of the catheter over the guide wire. This fills the excess space where air can get trapped and the lubricating qualities of the material also allows easy insertion of the guidewire through the shaft thereby removing the need for flushing with a saline solution or lubricant. The flushing step is thereby eliminated and consequently, the use of a needle and syringe is also eliminated.
The present invention relates to a non-flush catheter device comprising at least one elongated tubular member having an inner surface and an outer surface, a proximal and a distal end. The inner surface of the elongated tubular member defines a guide member lumen and is at least occasionally subjected to contact with at least one guide member. The guide member is filled with a lubricious material.
More specifically, the present invention relates to non-flush over the wire (OTW) catheter devices, and in particular to non-flush rapid exchange (RX) or single operator exchange (SOE) catheter devices. In an RX/SOE, the device comprises at least one elongated tubular member having an inner surface and an outer surface, a proximal end and a distal end, and an opening located between said proximal and distal end. The elongated tubular member has a guide member lumen therein. The inner surface of the elongated tubular member defines the guide member lumen and is at least occasionally subjected to contact with at least one guide member. The opening for receiving said guide member and the guide member lumen are filled with a lubricious material.
The lubricious material fills the excess space in the lumen thereby eliminating trapped air and lubricates the inner surface of the elongated tubular member thereby making insertion of the guide member easier. The lubricious material thereby eliminates the need for flushing the catheter device prior to insertion of the device over the guide member.
More specifically, the elongated tubular member is a catheter shaft. The catheter shaft may further comprise an inner shaft having an inlet port for receiving a guide wire.
In some specific embodiments, the tubular member comprises at least one thermoplastic polymer, and the guide member comprises at least one metal, or may be an alloy of metals.
Even more specifically, the present invention relates to an SOE or RX catheter device having proximal and distal ends comprising a polymeric shaft having an inner surface and proximal and distal ends. The shaft is open at the proximal and distal ends. A guide wire lumen is carried in the shaft and defined by the inner surface of the shaft. The shaft further has a guide wire port for receiving a guide wire, the port being located between the proximal and distal ends of the device. A lubricious material fills the guide wire lumen.
The present invention further relates to an SOE or RX non-flush catheter device comprising a sheath wherein a guide member is adapted to be inserted into a patient""s vasculature so that a distal portion of the guide member is within the patient and a proximal portion thereof remains outside the patient. The sheath comprises an elongated tubular member having an inner surface defining a single longitudinally extending lumen sized to slidably receive a guide member therein. The tubular member has a distal insertion opening in communication with the lumen adjacent its distal end, a proximal insertion opening in communication with the lumen adjacent its proximal end, and a side hole port in communication with the lumen for receiving the guide member. The guide member lumen is filled with a lubricious material.
The lubricious material fills any excess space in the lumen of the devices described above, displacing the trapped air, preventing contaminants from reentering the device, and lubricating the inner surface of any elongated tubular member, shaft or sheath that defines the guide member lumen.
The present invention further relates to a method of eliminating the need for flushing a catheter device prior to insertion over a guide member and into the vasculature of a patient comprising the steps of providing a catheter shaft having an inner surface and an outer surface wherein the inner surface of the catheter shaft defines a guide wire lumen, filling the guide wire lumen with a lubricious material and storing the catheter device for a period of time prior to use. This latter step eliminates the need for flushing the device immediately prior to or during the surgical procedure.